Integrative music therapy for depression-related disorders
| ISRCTN | ISRCTN26812986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26812986 |
| Secondary identifying numbers | Research Council of Finland Grant 346210 |
- Submission date
- 10/04/2024
- Registration date
- 12/04/2024
- Last edited
- 19/06/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study focuses on depression-related disorders often faced by working-age individuals. The RCT’s intervention is targeted at those individuals who are in employment, in their studies, temporarily unemployed, on short-term sick leave or rehabilitation allowance, and who suffer from disorders, or problems that impair their overall ability to function. In the context of this study, depression-related disorders or problems mean depression, anxiety, work-related stress, and burnout. The interventions applied are integrative improvisational music therapy (IIMT), music listening (ML) added to the IIMT, vibroacoustic stimulation (VA) added to the IIMT, and both ML and VA added to the IIMT. All sessions will begin with a preparation exercise called Resonance Frequency Breathing (RFB) to enhance the effect of the therapy. Clinically trained music therapists will conduct the interventions. The study aims to investigate if the interventions reduce psychological distress and improve functioning and quality of life.
Who can participate?
Working-age adults aged between 18-65 years old with one or several of the following disorders: depression, anxiety, workplace stress, or burnout
What does the study involve?
All the participants will get the intervention for 6 weeks (biweekly sessions, 60 minutes each). The participants will be randomised into four groups that will have different modifications of the intervention (the plain IIMT group will be a waiting-list control). The primary outcome will measure psychological distress. Secondary outcomes will look at depression, anxiety, exhaustion, burnout, health-related quality of life and problems feeling emotions (alexithymia).
What are the possible benefits and risks of participating?
It is assumed that 1) the clients who receive IIMT will improve significantly more than the control group; 2) when ML precedes IIMT, it stimulates a client emotionally as well as raises personal themes thus making improvisational working more productive; 3) when VA precedes IIMT, it helps a client to release stress, and helps a client to make observations on both physical and mental domains of experiences; 4) when both ML and VA precedes IIMT, the combination effect is stronger than either of them alone; and, 5) productive improvising can be differentiated from non-productive, and that it is based on rhythmic aspects of music. Temporary weakening of the client’s condition, issues dealing with RFB included in IIMT and issues dealing with VA are potential risks of participating in the study.
Where is the study run from?
The Music Therapy Clinic for Research and Training, at the Department of Music, Art and Culture Studies, at the University of Jyväskylä, Finland.
When is the study starting and how long is it expected to run for?
The study started in January 2022 and will run until December 2029. The recruitment of the participants will begin in May 2024.
Who is funding the study?
The Research Council of Finland and the University of Jyväskylä.
Who is the main contact?
Dr Esa Ala-Ruona, esa.ala-ruona@jyu.fi
Contact information
Scientific, Principal Investigator
Department of Music, Art and Culture Studies, University of Jyväskylä, P.O. Box 35 (M)
Jyväskylä
40014
Finland
 ORCID ID |
0000-0003-3873-5179 |
|---|---|
| Phone | +358408054297 |
| esa.ala-ruona@jyu.fi |
Public
Department of Music, Art and Culture Studies, University of Jyväskylä, P.O. Box 35 (M)
Jyväskylä
40014
Finland
| Phone | +358405707007 |
|---|---|
| markku.i.poyhonen@jyu.fi |
Study information
| Study design | Interventional randomized 2 x 2 factorial trial with a waiting list control |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Music therapy for working-age people with depression-related disorders – a randomised controlled trial combined with mixed methods research |
| Study acronym | iMTDep |
| Study objectives | Objective 1: Through this RCT, the aim is to find out whether Integrative Improvisational Music Therapy (IIMT), offered in four different modifications, improves the participant's condition. The study will also find out whether any of the modifications of the IIMT are superior to plain IIMT. Objective 2: To understand whether certain musical responsiveness or personality profiles explain a client’s improvement in music therapy. Objective 3: To increase understanding of the dynamics of therapeutic change by IIMT in its original form and with selected modifications. Objective 4: To increase understanding of the essence, mechanisms and trajectories of work-related stress and burnout and their relationship to depression and anxiety. Objective 5: To understand how functional connectivity in the brains of participants with depression changes before and after IIMT. Hypothesis 1: All the experiment groups improve significantly better than the control group. Hypothesis 2: Music listening (ML) + IIMT group improves significantly better than the IIMT-only group. Hypothesis 3: Vibroacoustic treatment (VA) + IIMT group improves significantly better than the IIMT-only group. Hypothesis 4: ML + VA + IIMT group improves significantly better than ML + IIMT, and VA + IIMT groups. Hypothesis 5: Increased interaction between client and therapist in musical behaviour correlates positively with the improvement shown by the psychiatric outcome measures. Hypothesis 6: Functional connectivity of participants with depression will change after the treatment and the change will be correlated with the improvement in the outcome measures. |
| Ethics approval(s) |
Approved 15/02/2024, Regional Medical Research Ethics Committee of Wellbeing Services County of Central Finland (Hospital Nova, Hoitajantie 3, Jyväskylä, 40620, Finland; +358142691811; eettinentoimikunta@hyvaks.fi), ref: 7U/2023 |
| Health condition(s) or problem(s) studied | Depression related disorders, e.g. depression, anxiety, work related stress and burnout. |
| Intervention | The study is a randomised 2 × 2 factorial trial using four conditions: integrative improvisational music therapy (IIMT), IIMT enhanced with music listening (ML), IIMT enhanced with vibroacoustic treatment (VA), and IIMT enhanced with both ML and VA. All sessions regardless of the condition will begin with a preparation exercise called Resonance Frequency Breathing (RFB). A therapy process consisting of 12 sessions, 60 minutes each, is offered to each of the groups. In addition, there will be a waiting-list control group to whom traditional IIMT will be offered after two months (equal to the approximate duration of the intervention) of the baseline measurements. There are overall four to five measurement points in this study: during the recruitment of the participants (baseline), 6 weeks after the beginning of the intervention (post-intervention), 6 months after the beginning of the intervention (first follow-up) and 12 months after the beginning of the intervention (second follow-up). The control group will have an additional measurement point 6 weeks after the baseline tests which also acts as a new baseline for the intervention. The measures conducted during the recruitment of the participants will also be the ones that determine participants’ eligibility for the study. In addition to the outcome measures demographics such as gender, age, and socio-economic background will be inquired at the beginning of the intervention. The health care professional, responsible for testing, will collect the health background information and possible changes in treatment and care during the testing appointments. |
| Intervention type | Behavioural |
| Primary outcome measure | Psychological distress measured using the Clinical Outcomes in Routine Evaluation - Outcome (CORE-OM) at baseline, 6 weeks, 6 months, and 12 months |
| Secondary outcome measures | The following secondary outcome measures are assessed at all time points at baseline, 6 weeks, 6 months, and 12 months: 1. Depression measured using the Montgomery Åsberg Depression Rating Scale (MADRS) 2. Anxiety measured using the Hospital Anxiety Depression Scale (HADS) 3. Exhaustion measured using the Karolinska Exhaustion Disorder Scale (KEDS) 4. Burnout measured using the Burnout Assessment Tool (BAT) 5. Health-related quality of life measured using the RAND 36-Item Health Survey 6. Alexithymia measured using the Toronto Alexithymia Scale (TAS-20) |
| Overall study start date | 01/01/2022 |
| Completion date | 31/12/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | Working-age adults (18-65 years of age) suffering from one or several of the following disorders: 1. Depression (ICD-10: F32 or F33), as screened by MADRS 2. Anxiety (ICD-10: F41), as screened by HADS-A 3. Work-place stress, or burnout, as screened by KEDS |
| Key exclusion criteria | 1. Psychosis 2. Personality disorder 3. Acute substance abuse 4. Difficulty in engaging in the study 5. Depression that is too severe for participation in therapy |
| Date of first enrolment | 05/06/2024 |
| Date of final enrolment | 31/12/2028 |
Locations
Countries of recruitment
- Finland
Study participating centre
Jyväskylä
FI-40014
Finland
Sponsor information
University/education
Seminaarinkatu 15, P.O. Box 35
Jyväskylä
40014
Finland
| Phone | +358142601211 |
|---|---|
| kirjaamo@jyu.fi | |
| Website | https://www.jyu.fi |
"ROR" |
https://ror.org/05n3dz165 |
Funders
Funder type
Government
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
Results and Publications
| Intention to publish date | 20/09/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and analysed during the current study are not expected to be made available for ethical restrictions. |
Editorial Notes
19/06/2024: The recruitment start date was changed from 01/05/2024 to 05/06/2024.
10/04/2024: Study's existence confirmed by the Regional Medical Research Ethics Committee of Wellbeing Services County of Central Finland.
